Manufacturing and controls submissions to IND's and NDA's for oral controlled release drug products

Abstract

The regulatory responsibilities of the Food and Drug Administration, in regard to manufacturing and controls, for oral controlled release drug products are reviewed. The requirements for IND and NDA submissions are outlined, with emphasis on quality control and documentation. The importance of submitting adequate scientific and technical data on which a reviewing chemist can make a meaningful review is discussed. Submission of the data in a format that not only documents the scientific data but also presents it in a clear and cogent manner is discussed. The discussions will include manufacturing, packaging and stability documentation for both clinical supplies and the commercial product.